K Number

Device Name

Eneka Pro

Manufacturer

TermoSalud

Date Cleared

2023-02-10

(64 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include: · Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. - · Treatment of Pseudofolliculitis barbae (PFB). - · Use on all skin types (Fitzpatrick I-VI)

Device Description

The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Primelase (K191321)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser hair removal system with adjustable parameters (pulse width, frequency, power) and different handpieces. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML for tasks like image analysis, treatment planning, or parameter optimization based on patient data. The performance studies focus on electrical and laser safety standards, and software verification/validation, not on AI/ML model performance.

Therapeutic

No.

The device is intended for permanent reduction in hair regrowth and treatment of Pseudofolliculitis barbae (PFB), which are aesthetic and cosmetic procedures, not therapeutic medical treatments for diseases or disorders.

Diagnostic

The device is described as a hair removal system, which is a therapeutic rather than diagnostic function. Its intended use is for permanent reduction in hair regrowth and treatment of Pseudofolliculitis barbae, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "non-invasive diode laser based system" with "2 handpieces," indicating it is a hardware device that utilizes laser technology for hair removal. While software verification and validation were conducted, the core functionality and components are hardware-based.

IVD (In Vitro Diagnostic)

Based on the provided information, the Eneka Pro diode laser hair removal system is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Eneka Pro Function: The Eneka Pro is a laser system that directly interacts with the human body (skin and hair follicles) for the purpose of hair removal and treatment of pseudofolliculitis barbae. It does not analyze samples taken from the body.
Intended Use: The intended use clearly describes a therapeutic and cosmetic application (hair removal and treatment of a skin condition) performed directly on the patient.
Device Description: The description details a laser system with handpieces for direct application to the skin.

Therefore, the Eneka Pro falls under the category of a therapeutic or cosmetic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Verification and validation activities were successfully completed and establish that the Eneka Pro performs as intended. Testing included the following: IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices. Clinical Evidence – N/A. No clinical studies were conducted as part of this submission. The Eneka Pro and Primelase Diode Lasers are nearly identical in the specifications. They have small differences in the design that do not impact the safety or effectiveness of the subject device, but only impact the user experience. The two devices can be considered substantially equivalent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Primelase (K191321)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.

February 10, 2023

TermoSalud % Connie Hoy Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K223680

Trade/Device Name: Eneka Pro Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 8, 2022 Received: December 8, 2022

Dear Connie Hoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K223680

Device Name Eneka Pro

Indications for Use (Describe)

Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:

· Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Treatment of Pseudofolliculitis barbae (PFB).
· Use on all skin types (Fitzpatrick I-VI)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K223680

510(K) Summary Eneka Pro

This 510(K) Summary of safety and effectiveness for the Eneka Pro is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant	TermoSalud
Address	Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain
Contact Person	Connie Hoy, Regulatory Consultant
Contact Information	conniehoy@hoyregulatory.com
(530) 908-4903
Preparation Date	December 8, 2022
Device Trade Name	Eneka Pro
Common Name	Powered Laser Surgical Instrument
Regulation Number	21 CFR 878.4810
Product Code	GEX
Regulatory Class	II
Legally Marketed Predicate
Device	Primelase (K191321)

Device Description:

Indications for use:

Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:

. Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI)

510(K) Summary Eneka Pro

Substantial Equivalence—Technological Characteristics:

Specification	Subject Device	Predicate Device	Comparison
Principle of	AlGaAs Laser diode	AlGaAs Laser diode	Same
operation	array	array
Laser Wavelength	808nm	755 nm,
810 nm,
810 - 1060 nm	Same. This
submission includes 2
handpieces with
808nm wavelength,
whereas the predicate
has additional
handpieces with other
wavelengths. The
indications for use in
this submission are
only for those with
the Predicate's 810nm
handpiece
Laser Contact	Sapphire, AL203	Sapphire, AL203	Same
Spot Sizes	20x9mm (1.8cm2),
34x14mm (4.75cm2)	20x9, 30x9, 30x17	1 same, 1 different.
The spot size for the
Eneka Pro XL
handpiece is identical
to the predicate. The
dimension of the 2XL
handpiece is nearly
identical to the
predicate. The
dimension very
slightly, but the total
area is within .5cm of
the predicate.
Fluence	40J/cm2	80 J/cm2	Different. Though the
fluence of the
predicate device is
higher, this is not the
actual fluence used in
treatment (see next
row)
Maximum fluence
actually used (as per
treatment protocols)	40J/cm2	43 J/cm2	Different. The
fluence of the Eneka
Pro is marginally
lower than the
predicate but
			functionally they are
			the same
Frequency	1-4Hz (Dynamic)
5-10Hz (Fast
Dynamic)	UP TO 3 Hz (static)
5 - 10 Hz (dynamic)	Same. The overall
frequency range of
the two devices are
the same.
Pulse Duration	5ms-400ms	3 - 400 ms/ AUTO (3 ms)	Different. The
predicate's low end
pulse duration is
marginally higher
than the Eneka Pro
but it does not impact
treatment.
Treatment Mode	Dynamic and Fast
Dynamic	Static and Dynamic	Same. The Eneka Pro's
Dynamic mode
functions the same as
the predicate's Static
mode, and the Eneka
Pro's Fast Dynamic
mode function the same
as the predicate's static
mode. Details on their
frequencies are in the
table below. The
difference are only in
marketing terminology.
Tissue Cooling	Contact cooling
system	Contact cooling system	Same.
Cooling Temperature	3 °C	5°C	Different.
User Interface	LCD Touchscreen	LCD Touchscreen	Same.
Pulsing Control	Finger Switch	Finger Switch	Same.
Configuration	Main unit and
handpiece	Main unit, handpiece,
and foot control
(optional)	Same
Laser Classification	IV	IV	Same.
Power Supply	115 V a.c 50/60 Hz	Single Phase, 100-
240V, 50-60Hz	Different.
Dimension	620 mm x 430 mm x
630 mm	1140 x 480 x 550 mm	Different.
Weight	32 Kg	75 Kg	Different.

Performance Testing

Verification and validation activities were successfully completed and establish that the Eneka Pro performs as intended. Testing included the following:

510(K) Summary Eneka Pro

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests

IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.

Conclusion

The Eneka Pro and Primelase Diode Lasers are nearly identical in the specifications. They have small differences in the design that do not impact the safety or effectiveness of the subject device, but only impact the user experience. The two devices can be considered substantially equivalent.